Orange Book product · Brand (NDA)

XELPROS

LATANOPROST

Brand (NDA)NDA 206185DISCN SUN PHARM

Sep 12, 2018

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Sep 12, 2018
7 yr 11 mo ago
Today
Patent 9539262 expires
Listed method-of-use patent (U-2400) expiration.
Oct 15, 2028
in 2 yr 4 mo
Patent 9629852 expires
Listed drug product patent expiration.
Sep 12, 2029
in 3 yr 3 mo

Active ingredient

LATANOPROST

Strength

0.005%

Dosage form

EMULSION

Route

OPHTHALMIC

TE code

Not listed

Application

NDA 206185

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

Yes

Reference standard (RS)

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
9539262	Oct 15, 2028	in 2 yr 4 mo	U-2400
9629852	Sep 12, 2029	in 3 yr 3 mo	Product